Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT05911503
Status:
RECRUITING
Last Update Posted:
2023-06-23
First Post:
2023-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of High Concentration Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017726', 'term': 'Cytomegalovirus Retinitis'}], 'ancestors': [{'id': 'D015828', 'term': 'Eye Infections, Viral'}, {'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003586', 'term': 'Cytomegalovirus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012173', 'term': 'Retinitis'}, {'id': 'D012164', 'term': 'Retinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-21', 'studyFirstSubmitDate': '2023-06-04', 'studyFirstSubmitQcDate': '2023-06-19', 'lastUpdatePostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fundus lesions', 'timeFrame': '24 weeks', 'description': 'The size changes of fundus lesions after medication are recorded'}], 'secondaryOutcomes': [{'measure': 'Change In LogMAR Best Corrected Visual Acuity (BCVA)From Baseline to Each visit', 'timeFrame': '24 weeks', 'description': 'The size changes of fundus lesions after medication are recorded'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cytomegalovirus Retinitis', 'Ganciclovir Eye Drops']}, 'descriptionModule': {'briefSummary': 'Clinical study of high concentration ganciclovir eye drops in the treatment of cytomegalovirus retinitis', 'detailedDescription': "Approval of the study was obtained from the hospital's ethical committee. The study design and methodology followed the tenets of Declaration of Helsinki. All patients were provided with written informed consent and received a thorough explanation of the use of 2% Ganciclovir Eye Drops, its potential risks and benefits. This is a monocencer, single arm, prospective study. The experimental group is: 2% Ganciclovir Eye Drops therapy group.\n\nAdministration method and dose adjustment: 2% ganciclovir eye drops, 10 times / day for two weeks, 8 times/day for two weeks, 6 times/day for two weeks, 4 times/day for more than six weeks.\n\nAccording to best corrected visual acuity (BCVA), intraocular pressure, corneal abrasion, anterior chamber and vitreous inflammation, optical coherence tomography (OCT), Ultra wide angle fundus image and so on. The investigators evaluate the effects of 2% Ganciclovir Eye Drops in treatment of cytomegalovirus retinitis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients voluntarily participate in studies and sign informed consent forms\n2. Ages 2-80 years (with cut-off values) male and female\n3. One of the following is true （1）In patients with cytomegalovirus retinitis after hematopoietic stem cell transplantation/cord blood transplantation, the white blood cell count is less than 4× 10\\^9/L, and the platelet count ranges are 25× 10\\^9/L≤ PLT\\<100×10\\^9/L，Intravitreal injection carries a greater risk of infection and bleeding, and is unable to administer systemic medication due to the bone marrow suppression of antiviral drugs, or systemic medication for severe CMV retinitis cannot be well controlled; （2）In patients with CMVR with AIDS, the CD4+ T cell count is less than 100/μl, there is a great risk of infection with intravitreal injection, and the systemic medication of severe CMV retinitis cannot be well controlled.\n\nExclusion Criteria:\n\n* Eye condition\n\n 1. The presence of refractive interstitial opacification affects fundus observation;\n 2. Intravitreal ganciclovir or sodium phosformate injections were performed within 1 week prior to baseline;\n 3. Other diseases that can affect visual function such as syphilis-related eye diseases, acute retinal necrosis, congenital glaucoma, congenital corneal lesions, congenital macular degeneration, etc.\n* General condition\n\n 1. Severe neutropenia (\\<0.5×10\\^9) or severe thrombocytopenia (\\< 25× 10\\^9/L);\n 2. Other investigators judged patients who were not suitable for enrollment;'}, 'identificationModule': {'nctId': 'NCT05911503', 'briefTitle': 'Clinical Study of High Concentration Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University'}, 'officialTitle': 'A Clinical Study of High Concentration(2%) Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis', 'orgStudyIdInfo': {'id': '2023KY-23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2% Ganciclovir Eye Drops therapy Group', 'description': 'Administration method and dosage adjustment: 2% ganciclovir eye drops, 10 times/day for two weeks, 8 times/day for two weeks, 6 times/day for two weeks, 4 times/day for more than 6 weeks', 'interventionNames': ['Drug: 2% Ganciclovir Eye Drops']}], 'interventions': [{'name': '2% Ganciclovir Eye Drops', 'type': 'DRUG', 'description': 'Administration method and dosage adjustment: 2% ganciclovir eye drops, 10 times/day for two weeks, 8 times/day for two weeks, 6 times/day for two weeks, 4 times/day for more than 6 weeks', 'armGroupLabels': ['2% Ganciclovir Eye Drops therapy Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300000', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xiaomin Zhang', 'role': 'CONTACT', 'email': 'xiaomzh@126.com', 'phone': '+8613920023990'}], 'facility': 'Tianjin Medical University Eye Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'xiaomin Zhang', 'role': 'CONTACT', 'email': 'xiaomzh@126.com', 'phone': '+8613920023990'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator,MD,PhD', 'investigatorFullName': 'Xiaomin Zhang', 'investigatorAffiliation': 'Tianjin Medical University'}}}}